...RESTON Va.SNM will devote its annual Molecular Imaging Summit to intr... Attendance at this workshop is a must for imaging centers pharmaceut...The goal of SNM's Clinical Trials Network is to bring together the pha...Several discussions between FDA and SNM have surfaced on this issue of...

RESTON, Va.SNM will devote its annual Molecular Imaging Summit to introducing the new SNM Clinical Trials Network, Feb. 8𔃇, 2009, at the Hilton Clearwater Hotel, Clearwater, Fl. In part, the program will explain requirements of participation in the Clinical Trials Network, which was designed to facilitate cost-effective drug development through the integration of imaging biomarkers into Phase 1, 2, 3 and 4 therapeutics clinical trials. In addition, the workshop will explore key issues involved with imaging participation in multi-center trials.

"Attendance at this workshop is a must for imaging centers, pharmaceutical manufacturers and others who wish to be involved with the SNM's Clinical Trials Network," said Robert W. Atcher, Ph.D., M.B.A, president of SNM. "This intensive two-day program will outline the nuts and bolts of the network and requirements for participation."

The goal of SNM's Clinical Trials Network is to bring together the pharmaceutical industry, the imaging community, biomarker manufacturers and regulatory agencies and provide them with processes, standards and protocols to streamline the use of imaging in the development and testing processes for new pharmaceuticals. The use of imaging in clinical trials can help pharmaceutical developers determine earlier in the development process whether a new product is clinically promisingaccelerating the development of these promising drugs and eliminating those without apparent patient benefit. However, including these investigational imaging biomarkers in clinical trials for investigational therapeutics poses challenges for a drug development company, including a lack of standardized imaging methods and challenging regulatory approval or paperwork requirements for the imaging biomarker.

Several discussions between FDA and SNM have surfaced on this issue of limited harmonization of imaging protocols between multiple imaging centers. The use of a consistent methodology and protocol is key to quality data generation and ultimate FDA approval of investigational therapeutics.

"It is important that interested imaging centers, drug manufacturers and other facilities get involved at this time as there are steps to be taken to ensure imaging standardization and to maintain imaging quality control across multiple sites," added Atcher. "This workshop will give members of the molecular imaging community an overview of the network and specific steps that participating imaging sites can take to ensure that they are qualified for participation in therapeutic clinical trialsand remain qualified over time. Speakers from the Food and Drug Administration, National Cancer Institute, pharmaceutical development industry and the imaging community will share their thoughts on specific needs for imaging biomarkers in drug development and the unique issues involved with incorporating imaging into multi-center clinical trials.

This comprehensive workshop will be held immediately after SNM's Mid-Winter Educational Symposium. It is slated to include presentations and discussions about: methods and short-comings of current drug development practices; the potential for imaging biomarkers in multi-center clinical trials; the role of the Clinical Trials Network in drug development; and fundamentals of participation in this network. SNM will discuss the specific goals and detailed plans of the Clinical Trials Network, including the roles and responsibilities of participation in network imaging and manufacturing registries, the phantom program and the 2009 F-18-fluorothymidine (FLT) demonstration project. Representatives from drug trial sponsors will discuss the specific needs for imaging in multi-center clinical trials.

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